DETECTion of PeriOperative Atrial Fibrillation After Noncardiac Surgery

NCT06519747 | Recruiting

• 1 other identifier: 2023-DETECTPOAF
• Study Type: observational
• Target: 750
• Locations: 1 country
• Sites: 6

Brief Summary

This is a multicentre prospective cohort study where patients will receive up to 14 days of continuous ECG monitoring by wearing a portable monitoring device, starting within 72 hours after noncardiac surgery.

Conditions

Atrial Fibrillation; Atrial Flutter

Keywords

Cardiac monitoring

Outcome Measures

Primary Outcomes (1)

• Incidence of clinically important post-operative atrial fibrillation/atrial flutter

  The primary outcome is clinically important POAF, defined as: 1. Atrial fibrillation (AF) documented by a 12-lead ECG; 2. Confirmed AF (e.g., rhythm strip) that results in symptoms of angina, heart failure, or symptomatic hypotension; 3. Confirmed AF that requires treatment with a rate controlling drug, antiarrhythmic drug, or electrical cardioversion; or, 4. Confirmed continuous AF episode with a minimum duration of 1 hour.

  Within 35 days of non-cardiac surgery

Secondary Outcomes (10)

• Incidence of sustained ventricular arrhythmia

  Within 35 days of non-cardiac surgery

• Incidence of sinus node dysfunction

  Within 35 days of non-cardiac surgery

• Incidence of high-grade atrioventricular block

  Within 35 days of non-cardiac surgery

• Incidence of death

  Within 35 days of non-cardiac surgery

• Incidence of clinically important post-operative atrial fibrillation/atrial flutter

  Within 14 days of continuous cardiac monitoring

Study Arms (1)

Study Cohort

Participants will receive up to 14 days of continuous cardiac monitoring

Device: Cardiac monitoring device

Interventions

Cardiac monitoring device DEVICE

Portable, up to 14 days of monitoring

Study Cohort

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults who have undergone noncardiac surgery

You may qualify if:

• Had undergone noncardiac surgery within the past 72 hours and requiring, or expected to require, at least one of the following:
• an overnight hospital admission after surgery
• day surgery that would result in a large enough physiological insult to be able to cause POAF. Procedures excluded include those that are conducted using local anesthesia alone, are less than 30 minutes in duration, and/or are judged to be of low physiologic insult by the local investigator.
• Have one of the following high-risk criteria;
• age 55-64 years, and having either established cardiovascular disease, recent major vascular surgery, a CHA2DS2-VASc score ≥3, or an elevated postoperative troponin level;
• age 65-74 years, and having either established cardiovascular disease, recent major vascular surgery, a CHA2DS2-VASc score ≥2, or an elevated postoperative troponin level; or
• age ≥75 years;
• Provide written informed consent to participate.

You may not qualify if:

• History of documented chronic (i.e., non-transient) AF before noncardiac surgery;
• Need for long-term systemic anticoagulation;
• Ongoing need for long-term dual antiplatelet treatment;
• Contraindication to oral anticoagulation;
• Severe renal insufficiency;
• Severe liver cirrhosis;
• Acute stroke in the past 14 days;
• Underwent cardiac surgery in the past 35 days;
• History of nontraumatic intracranial, intraocular, or spinal bleeding;
• Hemorrhagic disorder or bleeding diathesis;
• Known life expectancy \<1 year due to concomitant disease;
• Women who are pregnant, breastfeeding, or of childbearing potential not taking effective contraception;
• Expected to be non-compliant with follow-up and/or device use;
• Known contact allergy to monitoring device and/or its peripheral components;
• Previously enrolled in DETECT-POAF.

Sponsors & Collaborators

• Population Health Research Institute: lead

Study Sites (6)

Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

RECRUITING

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

NOT YET RECRUITING

Juravinski Hospital

Hamilton, Ontario, L8V 1C3, Canada

RECRUITING

London Health Sciences Centre - University Hospital

London, Ontario, N6A 5A5, Canada

NOT YET RECRUITING

Niagara Health System - St. Catharine's Site

St. Catharines, Ontario, L2S 0A9, Canada

NOT YET RECRUITING

Hôpital Fleurimont du Centre hospitalier universitaire de Sherbrooke

Sherbrooke, Quebec, J1H 5H3, Canada

NOT YET RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation; Atrial Flutter

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• David Conen, MD, MPH

  Population Health Research Institute

  PRINCIPAL INVESTIGATOR

• Michael K Wang, MD

  Population Health Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vitheya Thanabalan

CONTACT

+1 905-296-2710; detectpoaf@phri.ca

Kate Brady

CONTACT

detectpoaf@phri.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2024
• First Posted: July 25, 2024
• Study Start: October 15, 2024
• Primary Completion (Estimated): August 15, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 7, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (6)